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| United States Patent |
5,769,091
|
|
Simon
, et al.
|
June 23, 1998
|
Urethral plug having adhesive for enhanced sealing capabilities and
method of using said plug
Abstract
A novel urethral plug having adhesive thereon, wherein the adhesive seals
the plug against the tissues surrounding the meatus and/or urethra,
thereby arresting movement of the plug while it functions in the urethra
to block the flow of urine. The urethral plug comprises a hollow or solid
body which is of a sufficient length and diameter to occlude the urethra.
In one embodiment, adhesive is disposed on the meatal plate of the plug so
as to secure the plug against the tissues surrounding the urethral meatus.
In a second embodiment, adhesive is disposed on the body of the plug so as
to seal the plug against the urethral wall. In a third embodiment, the
adhesive is disposed on a portion of the meatal plate so as to seal the
plug against the tissues surrounding the urethral meatus. The adhesive
seals the urethral plug in place until the user wishes to void, at which
time, the seal may be broken by exerting a pulling force on the plug.
| Inventors:
|
Simon; John G. (Boston, MA);
McLaughlin; Paul D. (Scituate, MA);
Felice; Leo C. (Pascoag, RI);
Joshi; Sharad (Watertown, MA);
Syed; Azhar (Brookline, MA);
Tartacower; Richelle (Aktinson, NH);
O'Keefe; Jonathan (Hingham, MA)
|
| Assignee:
|
UroMed Corporation (Needham, MA)
|
| Appl. No.:
|
599636 |
| Filed:
|
February 9, 1996 |
| Current U.S. Class: |
128/885; 128/DIG.25; 600/29 |
| Intern'l Class: |
A61F 005/48 |
| Field of Search: |
128/885,DIG. 25
604/329,330,349-356
600/29-31
|
References Cited
U.S. Patent Documents
| 2324520 | Jul., 1943 | Lamson | 128/283.
|
| 2494393 | Jan., 1950 | Lamson | 128/1.
|
| 2638093 | May., 1953 | Kulick | 128/133.
|
| 3503400 | Mar., 1970 | Osthagen et al. | 128/349.
|
| 3646929 | Mar., 1972 | Bonnar | 128/1.
|
| 3726277 | Apr., 1973 | Hirschman | 128/285.
|
| 3789828 | Feb., 1974 | Schulte | 128/1.
|
| 3797478 | Mar., 1974 | Walsh et al. | 128/1.
|
| 3841304 | Oct., 1974 | Jones | 128/1.
|
| 3857394 | Dec., 1974 | Alemany | 128/260.
|
| 4019499 | Apr., 1977 | Fitzgerald | 128/1.
|
| 4258704 | Mar., 1981 | Hill | 128/1.
|
| 4261340 | Apr., 1981 | Baumel et al. | 128/1.
|
| 4428365 | Jan., 1984 | Hakky | 128/1.
|
| 4457299 | Jul., 1984 | Cornwell | 128/1.
|
| 4553533 | Nov., 1985 | Leighton | 128/1.
|
| 4563183 | Jan., 1986 | Barrodale | 604/329.
|
| 4568339 | Feb., 1986 | Steer | 604/329.
|
| 4682592 | Jul., 1987 | Thoregard | 128/303.
|
| 4822347 | Apr., 1989 | MacDougall | 604/329.
|
| 4846784 | Jul., 1989 | Haber | 600/29.
|
| 4850963 | Jul., 1989 | Sparks et al. | 600/29.
|
| 4938759 | Jul., 1990 | Enscore et al. | 604/896.
|
| 4946449 | Aug., 1990 | Davis, Jr. | 604/256.
|
| 4981465 | Jan., 1991 | Ballan et al. | 600/32.
|
| 5012822 | May., 1991 | Schwarz | 128/885.
|
| 5074855 | Dec., 1991 | Rosenbluth et al. | 604/385.
|
| 5090424 | Feb., 1992 | Simon et al. | 128/885.
|
| 5097848 | Mar., 1992 | Schwarz | 128/885.
|
| 5114380 | May., 1992 | Larsen | 452/176.
|
| 5114398 | May., 1992 | Trick et al. | 600/29.
|
| 5116387 | May., 1992 | Berg | 623/66.
|
| 5131906 | Jul., 1992 | Chen | 600/29.
|
| 5234409 | Aug., 1993 | Goldberg et al. | 604/96.
|
| 5336208 | Aug., 1994 | Rosenbluth et al. | 604/329.
|
| 5483976 | Jan., 1996 | McLaughlin et al. | 128/885.
|
| 5509427 | Apr., 1996 | Simon | 128/885.
|
| Foreign Patent Documents |
| WO 8810106 | Dec., 1988 | WO | .
|
| WO 8900030 | Jan., 1989 | WO | .
|
| WO 9004431 | May., 1990 | WO | .
|
| WO 9219192 | Nov., 1992 | WO | .
|
Other References
Nielsen et al., "The Urethral Plug: A New Treatment Modality For Genuine
Urinary Stress Incontinence in Women", copyright 1990, pp. 1199-1202,
Journal of Urology, vol. 144.
|
Primary Examiner: Brown; Michael A.
Attorney, Agent or Firm: Lorusso & Loud
Parent Case Text
CROSS REFERENCE TO A RELATED APPLICATION
This application is a continuation-in-part of U.S. application Ser. No.
08/124,264 filed Sep. 20, 1993 now U.S. Pat. No. 5,509,427, the teachings
of which are incorporated herein by reference.
Claims
What is claimed is:
1. A remove-to-void urethral plug having enhanced sealing capabilities
comprising:
a non-expandable, hollow body adapted to internally occlude the urethra,
the body having a substantially constant cross section, and
a meatal plate attached to the body, the meatal plate having a layer of
adhesive on at least a portion thereof for anchoring the meatal plate at
the urethral meatus.
2. The remove-to-void urethral plug according to claim 1 wherein the layer
of adhesive is positioned on the meatal plate so as to form a continuous,
discontinuous, spotty or uneven layer.
3. The remove-to-void urethral plug according to claim 1 wherein the
adhesive is selected from the group consisting of hydrogel adhesives,
polyvinylether-based adhesives, hydrocolloid adhesives, acrylic-based
adhesives, natural gum adhesives and synthetic rubber adhesives.
4. The remove-to-void urethral plug according to claim 1 wherein the meatal
plate has a configuration selected from the group consisting of a circular
shape, dumbbell shape, ovoid shape, and bow tie shape.
5. The remove-to-void urethral plug according to claim 1, further
comprising an appendage affixed to the meatal plate and extending
therefrom.
6. The remove-to-void urethral plug according to claim 1 wherein the body
includes curved indentations on the periphery thereof.
7. A remove-to-void urethral plug having enhanced sealing capabilities
comprising:
a non-expandable, hollow body adapted to internally occlude the urethra,
the body having a layer of adhesive on at least a portion thereof, and
a meatal plate for anchoring the body to the urethral meatus,
whereby the layer of adhesive seals the body against the wall of the
urethra such that movement of the plug is arrested.
8. The remove-to-void urethral plug according to claim 7, further
comprising a layer of adhesive on at least a portion of the meatal plate.
9. The remove-to-void urethral plug according to claim 8 wherein the layer
of adhesive is positioned on the meatal plate so as to form a continuous,
discontinuous, spotty or uneven layer.
10. The remove-to-void urethral plug according to claim 7 wherein the
adhesive is selected from the group consisting of hydrogel adhesives,
polyvinylether-based adhesives, hydrocolloid adhesives, acrylic-based
adhesives, natural gum adhesives and synthetic rubber adhesives.
11. The remove-to-void urethral plug according to claim 7 wherein the
meatal plate has a configuration selected from the group consisting of a
circular shape, dumbbell shape, ovoid shape, and bow tie shape.
12. The remove-to-void urethral plug according to claim 7, further
comprising an appendage affixed to the meatal plate and extending
therefrom.
13. The remove-to-void urethral plug according to claim 7 wherein the body
includes curved indentations on the periphery thereof.
14. A remove-to-void urethral plug having enhanced sealing capabilities
comprising:
a non-expandable body configured to extend into and internally occlude the
urethra, the body having a substantially constant cross section, and
a meatal plate attached to the body, the meatal plate having a layer of
adhesive on at least a portion thereof for anchoring the meatal plate at
the urethral meatus.
15. The remove-to-void urethral plug according to claim 14 wherein the
layer of adhesive is positioned on the meatal plate so as to form a
continuous, discontinuous, spotty or uneven layer.
16. The remove-to-void urethral plug according to claim 14 wherein the
meatal plate has a configuration selected from the group consisting of a
circular shape, dumbbell shape, ovoid shape, and bow tie shape.
17. The remove-to-void urethral plug according to claim 14 wherein the body
is hollow.
18. The remove-to-void urethral plug according to claim 14 wherein the body
is solid.
19. A remove-to-void urethral plug having enhanced sealing capabilities
comprising:
a non-expandable body adapted to extend into and internally occlude the
urethra, the body having a layer of adhesive on at least a portion
thereof, and
a meatal plate for anchoring the body at the urethral meatus,
whereby the layer of adhesive seals the body against the wall of the
urethra such that movement of the plug is arrested.
20. The remove-to-void urethral plug according to claim 19, further
comprising a layer of adhesive on at least a portion of the meatal plate.
21. The remove-to-void urethral plug according to claim 20 wherein the
layer of adhesive is positioned on the meatal plate so as to form a
continuous, discontinuous, spotty or uneven layer.
22. The remove-to-void urethral plug according to claim 19 wherein the
meatal plate has a configuration selected from the group consisting of a
circular shape, dumbbell shape, ovoid shape, and bow tie shape.
23. The remove-to-void urethral plug according to claim 19 wherein the body
is hollow.
24. The remove-to-void urethral plug according to claim 19 wherein the body
is solid.
25. A method of using a urethral plug having enhanced sealing capabilities
comprising:
providing a urethral plug having a non-expandable, hollow body
substantially constant in cross section and adapted to internally occlude
the urethra, the urethral plug further having a meatal plate attached to
the body, the meatal plate having a layer of adhesive on at least a
portion thereof for anchoring the meatal plate at the urethral meatus.
26. The method of using a urethral plug according to claim 25, further
comprising:
inserting the urethral plug into the urethra, bladder neck or bladder of a
user, in a position such that it blocks the flow of urine, and
adhesively anchoring the meatal plate at the urethral meatus,
whereby, when the urethral plug is in use, the layer of adhesive on the
meatal plate serves to anchor the meatal plate at the meatus, form a seal
between the meatal plate and the tissues surrounding the meatus, and
enhance a seal of the body to the urethral wall such that movement of the
plug is arrested.
27. The method of using a urethral plug according to claim 26, further
comprising removing the urethral plug to void.
28. A method of using a urethral plug having enhanced sealing capabilities
comprising:
providing a urethral plug having a non-expandable, hollow body adapted to
internally occlude the urethra, the body having a layer of adhesive on at
least a portion thereof, the urethral plug further having a meatal plate
attached to the body for anchoring the meatal plate at the urethral
meatus.
29. The method of using a urethral plug according to claim 28, further
comprising:
inserting the urethral plug into the urethra, bladder neck or bladder of a
user, in a position such that it blocks the flow of urine, and
adhesively retaining the body against the wall of the urethra to seal the
urethral plug in place without movement or slippage thereof from the
inserted position.
30. The method of using a urethral plug according to claim 29, further
comprising removing the urethral plug to void.
31. The method of using a urethral plug according to claim 28, further
comprising the step of providing the meatal plate with a layer of adhesive
on at least a portion thereof so as to seal the meatal plate against the
tissues surrounding the urethral meatus.
Description
FIELD OF THE INVENTION
This invention relates to the control of urinary incontinence and is
directed more particularly to a urethral plug having an adhesive coating
thereon, enabling the plug to maintain stability in the urethra.
BACKGROUND OF THE INVENTION
Urinary stress incontinence is the involuntary loss of urine when the
pressure within the urethra exceeds the maximum urethral pressure required
for maintaining closure or continence. Maximum urethral pressure is
exceeded during physical stress, or increased abdominal pressure, from
activities such as sneezing, laughing or lifting. While the problem of
urinary incontinence occurs in both men and women, it is an affliction
especially common in women of child bearing age and older.
There are in existence many methods used to address the problem of
incontinence, including surgical corrective techniques, surgically
implanted indwelling devices, physician prescribed and inserted indwelling
devices, and externally worn devices that collect or absorb urine. Each
method has its drawbacks.
Surgically implanted devices may not be appropriate for patients with mild
incontinence, or for those with other medical conditions that place them
at risk for surgery. Additionally, one must consider the costs of surgery.
There are also the problems of encrustation, irritation, infection, toxic
reactions to materials, and tissue necrosis with surgically implanted
devices. Moreover, surgically implanted devices traditionally have a low
long-term success rate.
Indwelling devices that are inserted into the urethra by a physician,
without involving surgical implantation, are also known. These devices are
inserted through the urethral orifice and allow the user to void either
past or through the device. These devices generally are complicated,
difficult to manufacture and, therefore, expensive. In practice, such
devices have proven difficult to use for the patient as they are
uncomfortable and can be cumbersome to manipulate to void. Additionally,
these devices, because they are indwelling, may cause some of the numerous
complications associated with surgically implanted devices, such as
encrustation, irritation and infection.
Also known are devices capable of being inserted by the user into the
urethra. Such devices are removed for voiding and then reintroduced into
the urethra upon completion of bladder evacuation. An example of such a
device is described by Neilsen, Kurt K. et al., in "The Urethral Plug: A
New Treatment Modality for Genuine Urinary Stress Incontinence in Women,"
J. Urology, vol. 44, p. 1100 (1990). This device consists of one or two
solid spheres located along a soft shaft, and a thin, soft plate located
at the end of the shaft. One sphere is located upstream of the maximum
urethral closing pressure point, corresponding to the location of the
sphincter. In the two sphere embodiment, the second sphere is located with
its midpoint at the bladder neck, and is used to assist in reducing
urinary flow and pressure transmission to the urethra so that the
sphincter can operate. One problem associated with this device is that the
patient must have three urethral closure pressure profiles performed, as
well as other examinations, before the device is custom made for the user.
Additional problems with this device include placement difficulties and
lack of sealing capabilities associated therewith, resulting in inadequate
retention and expulsion of the device from the urethra. In addition,
discomfort may occur with insertion and removal of the device, due to the
size profile and rigidity of the spheres, which spheres maintain a
constant diameter during insertion and removal.
Another "remove-to-void" device is disclosed in U.S. Pat. No. 5,090,424,
which comprises a conformable urethral plug. The body of the plug forms a
cavity which is in fluid communication with a second cavity via a
check-valve. Thus, fluid may be pumped into the cavity within the urethra
to provide a custom fit. This device, like others depending on fluids or
gels for expansion, relies heavily on a fluid-tight valve in order to
maintain retention. Should valve failure occur, evacuation would
immediately follow.
Certain external devices exist that do not require insertion into the
urethra, such as absorbent pads, diapers and the like. Such pads are
bulky, susceptible to migration, often lack effectiveness in preventing
leakage, and provide no effective protection against undesirable odor.
Moreover, these devices are expensive to use over time and are often
associated with skin problems of the user.
An example of an external device is disclosed in U.S. Pat. Nos. 5,074,855
and 5,336,208. This device employs adhesive to secure a pad to the
vestibule of the user, thereby preventing the escape of urine from the
urethra. However, there are disadvantages associated with such a device.
Due to the structure and function of the device, there is nothing to
increase urethral resistance to urine flow. Moreover, as such a pad is
designed only to be worn externally, it is subject to migration in the
course of one's daily movement and activities, even with the use of
adhesive, given the friction associated with undergarments contacting the
pad. Migration as such, increases the likelihood of accidents and leakage.
As evidenced by the above discussion, the prior art devices do not address,
or inadequately address, problems associated with the stability of urinary
incontinence devices. The prior art has not adequately addressed the need
for enhancing the retention and sealing capabilities of the urinary
devices.
Ideally, the problem of urinary incontinence is addressed with an easily
manipulable, remove-to-void device having enhanced retention and sealing
capabilities.
SUMMARY OF THE INVENTION
It is, therefore, an object of the invention to provide a urethral plug
that successfully manages the problems associated with urinary stress
incontinence, and avoids the risk of complications associated with known
devices.
Another object of the invention is to improve the degree of retention of a
urethral plug in the urethra.
A further object of the invention is to enhance the sealing ability of a
urethral plug with the urethral wall.
Another object of the invention is to enhance the sealing ability of a
urethral plug at the tissues surrounding the urethral meatus, such that
movement of the plug is arrested.
Another object of the invention is to prevent slippage of a urethral plug
while disposed in the urethra.
A further object of the invention is to increase the urethral resistance to
urine flow through the urethra.
It is yet another object of the invention to provide a urethral plug which
can be manipulated easily by the user.
Still another object of the invention is to provide a method of using a
urethral plug to control urinary incontinence.
These and other objects of the invention are carried out by a novel
urethral plug having adhesive thereon, wherein the adhesive seals the plug
against the tissues surrounding the urethral meatus or, alternatively, the
urethra. The plug comprises a solid or hollow body which is of sufficient
length and diameter to occlude the urethra to control incontinence. The
portion of the plug that functions to block the flow of urine is the body,
and the portion of the plug that serves to anchor the plug at the urethral
meatus is the meatal plate. An appendage is associated with the meatal
plate, and removal of the plug for bladder evacuation is easily
accomplished by grasping and/or pulling the appendage.
In on e embodiment of the invention, a layer of adhesive lies on the meatal
plate so as to secure the plug against the tissues surrounding the
urethral meatus. In a second embodiment of the invention, a layer of
adhesive lies on the body of the plug so as to seal the plug against the
urethral wall. In a third embodiment of the invention, an adhesive layer
lies on the outer circumference of the meatal plate so as to seal the plug
against the tissues surrounding the urethral meatus.
These and other advantages of the invention will be better appreciated from
the following detailed description of the preferred embodiments.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 shows a urethral plug of the invention having adhesive o n the
meatal plate.
FIG. 1A shows an alternative version of the distal portion of the urethral
plugs of the invention without a tab extending from the meatal plate.
FIG. 2 shows a urethral plug of the invention having adhesive on a portion
o f the body of the plug.
FIG. 3 shows a urethral plug of the invention having adhesive on a portion
of the meatal plate.
FIG. 4A shows a cross section along line A--A of the body of the urethral
plugs in FIGS. 1-2.
FIG. 4B shows an alternative cross section along line A--A of the body of
the urethral plugs in FIGS. 1-2.
FIG. 5 shows a perspective view of the meatal plate of the urethral plugs
in FIGS. 1-2.
FIGS. 6A-E show alternative configurations of the meatal plate of the
urethral plugs of the invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
At the outset, the invention is described in its overall aspects with a
more detailed description following. The present invention is a novel
urethral plug having adhesive thereon, wherein the adhesive secures the
plug against the tissues surrounding the urethral meatus or,
alternatively, the urethra. The urethral plug comprises a solid or hollow
body which is of sufficient length and diameter to allow occlusion of the
urethra. The urethral plug can be made of a soft, flexible biocompatible
material such as polyurethane, polyethylene, polypropylene, latex,
silicone, foamed urethane, cellulose, polyvinylchloride, DYNAFLEX (a
trademark of GLS Corporation, Cary, Ill., for a biocompatible
thermoplastic elastomer), KRATON (a trademark of Shell Chemical Company,
Houston, Tex., for a biocompatible thermoplastic elastomer), C-FLEX (a
trademark of Consolidated Polymer Technologies, Largo, Fla., for a
biocompatible thermoplastic elastomer) and the like.
The portion of the urethral plug of the invention that functions to block
the flow of urine is the body, and the portion of the plug that serves to
anchor the plug at the urethral meatus is the meatal plate. The anchoring
of the urethral plug at the meatus prevents the plug from migrating into
the bladder. An appendage is affixed to the meatal plate and/or body of
the plug, and removal of the plug for bladder evacuation is easily
accomplished by grasping and/or pulling the appendage.
In one embodiment of the invention, a layer of adhesive is disposed on the
meatal plate so as to secure the plug against the tissues surrounding the
urethral meatus. In a second embodiment of the invention, a layer of
adhesive is disposed on the body of the plug so as to seal the plug
against the urethral wall. In a third embodiment of the invention, an
adhesive layer is disposed on the outer circumference of the meatal plate
so as to seal the plug against the tissues surrounding the urethral
meatus.
The adhesives chosen for use in the present invention may be any adhesive
that comfortably bonds to tissue and can subsequently be removed
completely by mechanical force. Other objectives may be accomplished by
the selection of an appropriate adhesive, for example, it may be useful to
have an adhesive that has a low initial tack, but whose tackiness
increases in the presence of moisture. Alternatively, strong initial tack
may be desired for good long-term adhesion of the plug to the user's
tissues.
The adhesive may be selectively applied to the meatal plate and/or body of
the plug to provide a number of areas thereon with different adhesive
properties. For example, the adhesive may be applied to the meatal plate
in a spotty pattern, with each spot consisting of an adhesive with a
different property. Or, the layer of adhesive on the meatal plate may be
applied in a manner forming concentric rings of adhesive, each ring
consisting of an adhesive with a different property. The selected
adhesives will be chosen to optimize desired properties.
Preferred adhesives include, but are not limited to, hydrogel adhesives,
polyvinylether-based adhesives, hydrocolloid adhesives, acrylic-based
adhesives, and natural gum and synthetic rubber adhesives. Other
biocompatible adhesive materials known in the art may be used. A removable
sheet may be provided over the adhesive to protect the adhesive until the
urethral plug is to be used.
Referring first to FIG. 1, shown is a hollow urethral plug 10, having a
body 12 sized to allow occlusion of the urethra following insertion of the
plug. The length of the body 12 may extend beyond the urethra and into the
bladder neck or bladder. A meatal plate 14 is disposed at one end of the
body and prevents migration of the urethral plug 10 into the bladder. The
meatal plate 14 is a flanged type member having a tab 15, which serves
also to prevent migration of the plug 10 into the bladder and aids in
removal of the plug 10 when the user wishes to void. Alternatively, the
meatal plate 14 of the urethral plug 10 may be provided without the tab,
as shown in FIG. 1A.
The meatal plate 14 anchors the urethral plug 10 at the urethral meatus. To
carry out this function of anchoring, the meatal plate 14 is of a
thickness sufficient to withstand bodily compression during wear,
preferably on the order of 0.5 millimeter or greater. Disposed on the
meatal plate 14 is a layer of adhesive 16, preferably a hydrogel adhesive.
This adhesive layer 16 seals the meatal plate 14 against the tissues
surrounding the meatus following insertion of the urethral plug 10 into
the urethra, thereby ensuring a secure placement of the urethral plug 10.
An appendage, such as a string 18, is affixed to and extends from the
meatal plate 14 and/or body 12 for removal of the urethral plug 10 after
insertion. Alternatively, removal may be carried out by the tab 15, a ring
17 (FIG. 1A), or any other removal member adapted to extend from the
meatal plate 14 and/or body 12.
Line A--A represents the cross sectional view of the body 12, which will be
discussed further with reference to FIGS. 4A and 4B.
Upon insertion of the plug into the urethra, bladder neck and/or bladder,
the urethral wall conforms to the plug 10 via an automatic intrinsic
reflex of the urethral muscles. The layer of adhesive 16 on the meatal
plate 14 serves to anchor the meatal plate 14 at the tissues surrounding
the urethral meatus and create a seal therebetween. Retention of the body
12 against the urethral wall is thereby enhanced, such that movement of
the plug is arrested and continuous blockage of urine provided. The
adhesive layer 16, although shown to be continuous, may be discontinuous,
spotty or uneven, depending on the degree of adhesion desired and the
condition of the tissues of the user.
FIG. 2 shows an alternative embodiment of the urethral plugs of FIG. 1 and
1A. Shown is a urethral plug 20 having a layer of adhesive 26 on a portion
of the body 22. The adhesive layer 26, disposed in such a position,
secures the placement of the urethral plug 20 in the urethra by forming a
seal with the urethral wall. Upon insertion of the urethral plug 20 into
the urethra, bladder neck and/or bladder, the adhesive layer 26 bonds with
the urethral wall, such that the wall conforms to the urethral plug 20.
This results in a tight seal between the plug 20 and the urethral wall,
preventing the urethral plug 20 from moving in any direction. When voiding
is desired, the tab 25 of the meatal plate 24, and/or the string 28
affixed to and extending from the urethral plug 20, is grasped and pulled
downwardly. The seal between the adhesively-secured portion of the body 22
and the urethral wall is broken, and the urethral plug is removed. Note
that, although this figure shows a continuous layer of adhesive 26 on a
portion of the body 22, the adhesive layer 26 may be discontinuous, spotty
or uneven, depending upon the degree of adhesion desired and the condition
of the tissues of the user. Also, the portion of the body bearing the
adhesive layer shown in FIG. 2 is exemplary only, and the layer of
adhesive may be applied to any suitable portion of the body 22.
To further ensure secure placement of the urethral plug 20, the plug 20 may
include an adhesive layer on the meatal plate 24 (not shown) for
additional anchoring of the meatal plate 24 against the meatal tissues.
The adhesive layer on the meatal plate 24 may be continuous,
discontinuous, spotty or uneven. The meatal plate 24 may optionally
include a tab 25 extending therefrom.
FIG. 3 shows an alternative embodiment of the urethral plugs of the
invention, and for purposes of illustration only, a solid urethral plug 30
is shown. Note, however, that a hollow urethral plug is equally suitable
for this embodiment. In this embodiment, the urethral plug 30 has a meatal
plate 34 with a layer of adhesive 36 thereon. As provided above, the
meatal plate 34 may optionally include a tab 35. The adhesive layer 36 is
disposed on the meatal plate 34 so as to anchor and seal the urethral plug
30 against the tissues surrounding the urethral meatus. As shown, the
adhesive layer 36 is disposed on the outer circumferential portion of the
meatal plate 34, such that a space 37 exists between the adhesive layer 36
and the body 32 of the urethral plug 30. The space 37 is free of adhesive.
The urethral plug 30, with the adhesive layer 36 so disposed, functions to
seal the plug at a distance from the urethral meatus. When the user wishes
to void, removal is carried out in much the same manner as in the above
embodiments. The tab 35 of the meatal plate 34, and/or the string 38, is
grasped and pulled downwardly, which breaks the seal formed between the
adhesively-secured portion of the meatal plate 34 and the tissues
surrounding the urethral meatus. Although FIG. 3 shows a continuous layer
of adhesive 36, the adhesive layer may be discontinuous, spotty or uneven.
Moreover, this embodiment may optionally include a layer of adhesive on
the body 32, or portions thereof, of the urethral plug 30.
FIG. 4A shows a cross sectional view along line A--A of the urethral plugs
set forth above in FIGS. 1-2. Body 42 is representative of elements 12 and
22 of the aforementioned urethral plugs, and as shown, is of a
substantially constant diameter. FIG. 4B shows an alternative embodiment
of the urethral plugs, along line A--A. As shown, the diameter of the body
42 may include curved indentations 44 on the periphery of the body. The
indentations 44 provide enhanced surface area by which the urethral plugs
may more readily adapt to the urethral wall. Such enhanced sealing ability
of the urethral plugs provides a more secure fit for the user.
FIG. 5 shows a bottom perspective view of a meatal plate 54, which is
representative of meatal plates 14 and 24 in the embodiments of FIGS. 1-2.
A portion of the meatal plate 54 extends to form a tab 55, which may be
grasped by the user for ease of removal.
One skilled in the art will recognize that alternative shapes and
configurations can be used for the meatal plate of the urethral plugs of
the invention. FIGS. 6A-E illustrate alternative configurations suitable
to anchor the plugs to the tissues surrounding the urethral meatus. The
shape of the meatal plate will depend on such factors as the user's
comfort, gender, the ability of the plate's configuration to be anchored
and sealed, and ease of inserting and removing the urethral plug.
FIG. 6A shows the meatal plate 64 to be circular in shape. The circular
meatal plate may be either convex or concave, whichever is more suited for
the anatomy of the user. Other meatal plate configurations include, but
are not limited to, the dumbbell shape in FIG. 6B, the ovoid shape in FIG.
6C, the star shape in FIG. 6D and the bow tie shape in FIG. 6E.
The configurations of the meatal plate may comprise a three dimensional
contour, or may include fold lines to improve the conformability of the
meatal plate to the tissues surrounding the urethral meatus and/or the
labia.
The method of using the urethral plugs 10, 20 and 30 of the invention is
substantially the same. The user inserts the urethral plug into the
urethra, bladder neck and/or bladder until the meatal plate abuts and
anchors at the urethral meatus. At this point, the layer(s) of adhesive on
the meatal plate and/or body of the urethral plug forms a seal with the
tissues surrounding the meatus and/or urethra, thereby preventing movement
of the urethral plug. The urethral plug is now disposed in the urethra
such that it blocks the flow of urine therefrom. When the user wishes to
remove the urethral plug, a tug on the tab and/or other appendage, such as
a string or ring, breaks the seal formed between the tissues of the user
and the adhesive layer(s) on the meatal plate and/or body of the plug. The
body of the urethral plug is then withdrawn from the urethra. If desired,
a fresh urethral plug may be inserted in the manner set forth above.
While the invention has been particularly shown and described with
reference to the aforementioned embodiments, it will be understood by
those skilled in the art that various changes in form, composition and
detail may be made therein without departing from the spirit and scope of
the invention. Thus, any modification to the shape, configuration and/or
composition of the elements comprising the invention is within the scope
of the invention.
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